Researchers have long argued that a heralded spinal treatment sold by the nation’s largest device maker, Medtronic, was no better than an older one and possibly more risky. Now with the company’s help, they have the proof.

The evidence, published on Monday in a medical journal, is the first fruit of a movement aimed at helping doctors and patients make better treatment choices. Its goal is to have companies make clinical data about a drug or a medical device available to a wide range of researchers, not just a few handpicked ones.

The development is the latest step in an evolving, decade-long push by patient advocates to make the practice of medicine more transparent. As a result of that effort, companies have recently started disclosing their payments to doctors and medical journals now require researchers to reveal any financial ties to a study’s sponsor.

By getting companies to release study data, advocates say, outside experts can vet whether reports in medical journal about the tests are accurate and complete. The concern is that the reports, which doctors rely on to learn about a treatment, can be shaped not only by financial factors but also by the personal agendas of the researchers involved.

“To improve the care of patients, clinical trial data, protocols and results need to be made more widely available and shared for public benefit,” according to an editorial in Annals of Internal Medicine, which published the Medtronic-related reports.

Medtronic’s decision to release data about spinal treatment followed charges in 2011 in a medical journal that company-sponsored studies about the product had overstated its benefit and played down its risks. Other producers are weighing the impact of adverse publicity if they decide not to follow suit against the possible impact on sales if they do.

Such decisions by companies are likely to unfold slowly rather than in a rush. In October, the drug giant GlaxoSmithKline said that it would release the data from all clinical trials of a drug after one is approved or abandoned. In April, Roche, faced by growing demands, said it would soon release all data collected during studies of its popular influenza drug, Tamiflu.

The Medtronic product at issue, which was first sold in 2002, is a bioengineered bone growth protein called Infuse that is used in spinal fusion, a common procedure performed to reduce back pain. Starting about a decade ago, some studies, including those sponsored by Medtronic, reported in medical journals that Infuse produced superior patient outcomes than the traditional material used in the procedure, a bone graft, and posed little if any risk.

One 2003 report, for example, concluded that Infuse produced “statistically superior outcomes with regard to length of surgery, blood loss, hospital stay, reoperation rate, median time to return to work and fusion rates.”

Many of the Infuse reports were written by researchers who received millions of dollars over the years in consulting fees and other payments from Medtronic, including Dr. Thomas A. Zdeblick of the University of Wisconsin and Dr. J. Kenneth Burkus, a spine surgeon in Georgia. The early reports led to the widespread use of Infuse for the specific type of spinal fusion for which the Food and Drug Administration had given approval and by surgeons as an “off-label” treatment in other types of fusion procedures. By 2011, Infuse was used in about a quarter of the estimated 432,000 spinal fusions performed in this country each year, but by then it had become controversial because of its cost and growing safety complaints.

In 2008, for example, the F.D.A. warned that it had received reports of life-threatening complications when Infuse was used off-label to fuse together vertebrae in the upper, or cervical, portion of the spine.

The controversy reached a climax in 2011, when a medical publication, The Spine Journal, devoted an issue to reports that repudiated the Medtronic-sponsored research, calling it misleading and biased. The journal’s move was significant because it is published by the nation’s biggest group of spine surgeons, the North American Spine Society.

Experts involved in research, like Dr. Zdeblick and Dr. Burkus, defended their work and insisted that their ties to Medtronic had not influenced them. But facing a firestorm, Medtronic agreed in 2011 to provide $2.5 million to Yale University to oversee an independent review of study data.

Photo

The headquarters of Medtronic, which agreed to make clinical data about Infuse, its spinal treatment, available.Credit
Medtronic

The resulting examinations, published Monday, involved reviews by two separate teams.

One of the teams, headed by scientists at Oregon Health and Science University in Portland, reported that Infuse appeared to have no advantages over a bone graft and might pose patient risks, including possibly a small added risk of cancer.

The other team, led by researchers at the University of York in England, found that Infuse fused spinal vertebrae more quickly than a bone graft but that the added speed appeared to lack clinical relevance.

Both the British and Oregon teams found no significant difference between Infuse and a bone graft in measures critical to patients, like reducing pain or improving physical function.

In responding to the reports, an executive of Medtronic pointed to the British review, saying that it showed that Infuse was a safe and effective product for its approved use. “The move that we made to open up everything out there and hold them up to transparent treatment was the right thing to do,” said Christopher J. O’Connell, the president of Medtronic’s restorative therapies group.

A professor at Yale who oversaw the review, Dr. Harlan M. Krumholz, said that while the two teams had slightly different findings, they pointed in the same direction.

“The general, overall picture is that they failed to find a big benefit,” for Infuse, Dr. Krumholz said. “And they found there might be some harms.”

Doctors and patients, he said, could use the review’s information to decide which treatment was best for them.

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Infuse, a bone growth product from Medtronic, has been used with implanted devices like the one above.

Some reviewers also concluded that the Medtronic-financed research had — unwittingly or not — presented a misleading picture.

“Selective reporting or underreporting of outcomes in journal publications may have misrepresented the benefits and harms,” of Infuse, the Oregon group wrote.

Dr. Burkus did not respond to requests for comment. Dr. Zdeblick said in a statement that he had not misrepresented any findings. “The information that I contributed to the papers in question was correct and complete to the best of my knowledge at the time,” he stated.

Dr. Krumholz and others applauded Medtronic’s decision to release the trial data. The review’s results, however, are likely to lead to further drops in Infuse sales. Annual sales of the product, which stood at about $900 million before The Spine Journal’s issue devoted to it, were $528 million in the company’s most recent fiscal year.

Both the editor of The Spine Journal, Dr. Eugene J. Carragee, and the head of the North American Spine Society, Dr. Charles A. Mick, described the Yale project as laudable. But both men said that it was not a substitute for initial, unbiased research, adding that patients had suffered as a result of the Infuse episode.

In 2011, Dr. Carragee, a professor at Stanford, published a study suggesting that Infuse could pose a risk of male sterility. The Yale review, however, found study data on Infuse so limited that it was difficult to draw conclusions about that side effect and others.

Dr. Krumholz said he was hopeful that the Infuse review would lead more companies, as well as academic researchers, to disclose all the underlying data from their clinical research.

A version of this article appears in print on June 18, 2013, on page B1 of the New York edition with the headline: Wary Eye on Health Device. Order Reprints|Today's Paper|Subscribe